Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Phase 1

• Conditions: Haematological malignancy; MedDRA version: 19.0Level: PTClassification code 10042987Term: T-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10036543Term: Precursor T-lymphoblastic lymphoma/leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002739-14-FI
• Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-07
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

-Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
-Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration.
-Patients must have been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue).
-No more than 3 prior salvage therapies.
Are the trial subjects under 18? yes
Number of subjects for this age range: 7
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration.
- Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration.
- Clinical evidence of active central nervous system (CNS) leukemia.
- T-ALL with testicular involvement alone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of isatuximab.;Secondary Objective: -To evaluate the safety profile of isatuximab.<br>-To evaluate the duration of response (DOR).<br>-To evaluate progression free survival (PFS) and overall survival (OS).<br>-To evaluate the pharmacokinetics (PK) of isatuximab in patients with T-ALL or T-LBL.<br>-To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL.<br>-To assess minimal residual disease (MRD) and correlate it with clinical outcome.;Primary end point(s): Objective response rate;Timepoint(s) of evaluation of this end point: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1/ Duration of response - time<br>2/ Progression free survival - time<br>3/ Overall survival - time;Timepoint(s) of evaluation of this end point: 1-2-3 : 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1)